There are a wide variety of different diseases and physiological disorders associated with breathing, including sleep disorders such as sleep apnea and snoring, chronic obstructive pulmonary disease (CPOD), bronchitis, asthma and others. Many of these diseases and disorders may be treated by modifying the respiratory cycle.
For example, various oral or dental devices, such as the mandibular advancement device (MAD), have been developed for sleep apnea, and may be effective for treatment of mild sleep apnea, especially for patients that sleep on their back or stomach, and may improve airflow for patients with severe sleep apnea. These types of oral/dental devices may not be as effective, however, as continuous positive airway pressure devices (CPAP). Moreover, oral/dental devices are typically expensive, and may be associated with various side effects, including nighttime pain, dry lips, tooth discomfort, rearrangement in tooth and jaw positions, and excessive salivation, one or more of which may lead to reduced patient compliance.
CPAP devices will effectively control sleep apnea, but patient compliance may again be low, due for example to the discomfort of, and claustrophobic feeling associated with, the mask, pressure of the device, noise associated with the machine, entanglement of tubes, etc.
Other devices, as disclosed for example and without limitation in U.S. Pat. No. 7,735,491 to Doshi, U.S. Pat. No. 6,626,179 to Pedley and WO 2007/134458 to Robitaille, have been developed to treat sleep apnea and other respiratory disease and disorders by interfacing with the nasal passage of the user. Many of these types of nasal insert devices, however, may be difficult to properly install and/or use, for example requiring screwing of the device into the nasal passageway. In other systems, a holdfast, which secures the device to the user, may be external to the user, leading to lower levels of comfort and compliance. Conversely, internal holdfast systems may have a limited size variance, leading to such devices being either too tight or too loose, and/or adversely affecting the comfort level of the device and the associated compliance. Indeed, internal holdfast systems are often intended to create a tight seal with the nasal passageway, which may limit the population associated with any particular device.